Makmiragil (Tablets, Cream) Instructions for Use
ATC Code
G01AX05 (Nifuratel)
Active Substance
Nifuratel (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antibacterial drug, a derivative of nitrofuran
Pharmacotherapeutic Group
Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, except combinations with corticosteroids; other antimicrobial agents and antiseptics
Pharmacological Action
An antimicrobial drug, a derivative of nitrofuran. It has antiprotozoal, antibacterial, and antifungal action. It has low toxicity.
Highly active against Gram-positive and Gram-negative microorganisms (at MIC 12.5-25 µg/ml it suppresses from 44.3% to 93.2% of cultures).
Active against Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Shigella flexneri, Shigella sonnei, Salmonella typhi, Salmonella typhimurium, Salmonella enterica, Klebsiella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Morganella spp., Rettgerella spp., Pragia fontium, Budvicia aquatica, Rachnella aquatilis, Acinetobacter spp., other atypical enterobacteria, as well as protozoa (including against the causative agents of intestinal amoebiasis and giardiasis), fungi of the genus Candida, Trichomonas vaginalis; less active against Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa. Suppresses the activity of Lactobacillus acidophilus.
It is the drug of choice for the therapy of salmonellosis, shigellosis and other intestinal bacterial infections.
Especially effective against strains of Helicobacter pylori resistant to metronidazole.
Pharmacokinetics
After administration, it is rapidly absorbed from the gastrointestinal tract. It penetrates the blood-brain barrier and the placental barrier, and is excreted in breast milk. It is biotransformed in the liver and in muscle tissue. It is completely excreted in the urine (30-50% unchanged).
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to nifuratel: vulvovaginal infections; urinary tract infections; intestinal amoebiasis; giardiasis; chronic inflammatory diseases of the upper gastrointestinal tract associated with Helicobacter pylori.
ICD codes
| ICD-10 code | Indication |
| A06 | Amebiasis |
| A07.1 | Giardiasis |
| B98.0 | Helicobacter pylori as the cause of diseases classified elsewhere |
| K25 | Gastric ulcer |
| K26 | Duodenal ulcer |
| N10 | Acute tubulointerstitial nephritis (acute pyelonephritis) |
| N11 | Chronic tubulointerstitial nephritis (chronic pyelonephritis) |
| N30 | Cystitis |
| N34 | Urethritis and urethral syndrome |
| N41 | Inflammatory diseases of prostate |
| N76 | Other inflammatory diseases of vagina and vulva |
| ICD-11 code | Indication |
| 1A31 | Giardiasis |
| 1A36.Z | Amoebiasis, unspecified |
| DA60.Z | Gastric ulcer, unspecified |
| DA63.Z | Duodenal ulcer, unspecified |
| GA00 | Vulvitis |
| GA02.Z | Unspecified vaginitis |
| GA0Z | Inflammatory diseases of female genital tract, unspecified |
| GA91.Z | Inflammatory and other diseases of prostate, unspecified |
| GB50 | Acute tubulo-interstitial nephritis |
| GB51 | Acute pyelonephritis |
| GB55.Z | Chronic tubulo-interstitial nephritis, unspecified |
| GB5Z | Renal tubulo-interstitial diseases, unspecified |
| GC00.Z | Cystitis, unspecified |
| GC02.Z | Urethritis and urethral syndrome, unspecified |
| XN3DY | Helicobacter pylori (H. pylori) |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Cream
Intravaginally. The frequency of application depends on the dosage form used.
It is applied for 8 days or according to the doctor’s recommendations. If necessary, the treatment can be repeated after menstruation.
Tablets
For oral administration, a single dose for adults is 200-400 mg, for children – 10-30 mg/kg. The frequency of administration and duration of treatment depend on the indications.
Adverse Reactions
From the digestive system nausea, vomiting, bitter taste in the mouth, diarrhea, heartburn, gastralgia.
Allergic reactions skin rash, itching.
Contraindications
Hypersensitivity to nifuratel.
Use in Pregnancy and Lactation
Use during pregnancy is possible only for strict indications, when the intended benefit to the mother outweighs the potential risk to the fetus, because Nifuratel crosses the placental barrier.
If it is necessary to use the drug during lactation, the issue of discontinuing breastfeeding should be decided, because Nifuratel is excreted in breast milk.
Special Precautions
When treating vaginal infections, local therapy is carried out simultaneously with the oral administration of nifuratel.
During treatment, sexual intercourse should be avoided.
Drug Interactions
Nifuratel enhances the antifungal effect of nystatin.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Vaginal cream 100 mg+40000 IU/1 g: tubes 10 g, 15 g, 20 g, 25 g, 30 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g or 100 g in a set with an applicator
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
 |
Makmiragil | Vaginal cream 100 mg+40000 IU/1 g: tubes 10 g, 15 g, 20 g, 25 g, 30 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g or 100 g in a set with an applicator |
Dosage Form, Packaging, and Composition
Vaginal cream yellow, liquid, homogeneous.
| 100 g | |
| Nifuratel | 10 g |
| Nystatin | 4000000 IU |
Excipients : xaliphin 15 – 10 g, methylparahydroxybenzoate – 0.11 g, propylparahydroxybenzoate – 0.04 g, glycerol (glycerin) – 5 g, sorbitol solution 70% – 10 g, propylene glycol – 5 g, carbomer – 0.4 g, triethanolamine 30% – 1.5 g, purified water – up to 100 g.
10 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
15 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
20 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
25 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
30 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
40 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
50 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
60 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
70 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
80 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
90 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
100 g – aluminum tubes (1) in a set with a graduated applicator – cardboard packs.
Coated tablets, 200 mg: from 1 to 60 pcs.
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Makmiragil | Coated tablets, 200 mg: from 1 to 60 pcs. |
Dosage Form, Packaging, and Composition
Coated tablets white, round, biconvex.
| 1 tab. | |
| Nifuratel | 200 mg |
Excipients : corn starch – 60 mg, rice starch – 5 mg, macrogol 6000 (polyethylene glycol-6000) – 15 mg, talc – 30 mg, magnesium stearate – 2.5 mg, gelatin – 2.3 mg, acacia gum (gum arabic) – 2.3 mg.
Shell composition sucrose – 150 mg, magnesium carbonate – 33 mg, titanium dioxide – 0.9 mg, wax – 0.3 mg.
From 1 to 10 pcs. – contour cell packs (from 1 to 6 pcs.) – cardboard packs.
From 10 to 60 pcs. – bottles (1) – cardboard packs.
![Makmiragil [Tablets, Cream] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Makmiragil [Tablets, Cream] 2")